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The Double Blind Placebo Controlled Trial
The blind allegiance to what I call the “fool's gold standard” lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances. The exceptions are where: 1) there is no risk of harm if the patient forgoes treatment during the placebo phase such as in a trial for a drug that seeks to cure hair loss or impotence; 2) the standard therapy carries such severe side effects that patients might choose to avoid it; or 3) the standard therapy is otherwise of questionable efficacy. See, eg, Emanuel EJ, MD, PhD, Miller, FG, PhD: The Ethics of Placebo-Controlled Clinical Trials — A Middle Ground. N Engl J Med Vol. 345:915-919, (September 20, 2001), at http.//content.nejm.org/cgi/content/short/ 345/12/915?query=TOC; Hellman S: Of Mice But Not Men: Problems of the Randomized Clinical Trial. N Engl J Med, Vol 324 (May 30, 1991); Levine RJ: The Use of Placebos in Randomized Clinical Trials. IRB — A Review of Human Subject Research, Vol. 7, No.2, (March/April 1985); Bok S: The Ethics of Giving Placebos. Scientific American, Vol. 231, No. 5 (November 1974).
Still, sponsors and researchers continue to design and conduct such trials, providing the familiar excuse: “The FDA made us do it.” Indeed, in at least one case I have brought on behalf of an injured subject, I have seen the minutes of a meeting with an FDA official who advised the drug company that only a placebo controlled trial would be acceptable even though the drug company advised the official that standard therapy existed and there might be a risk of harm to the subject during the placebo phase. Even more startling is the response I have received in depositions of physician/principal investigators who believe such trials are the gold standard and are perfectly acceptable in the context of medical research as long as the subject signs the informed consent.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
'Insurable Interest' and the Scope of First-Party Coverage
This article reviews the fundamental underpinnings of the concept of insurable interest, and certain recent cases that have grappled with the scope of insurable interest and have articulated a more meaningful application of the concept to claims under first-party property policies.